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Clinical Trial NCT06689215 for Heart Failure, Congestive is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Comparison of Noninvasive vs. Invasive Hemodynamic Measurements 30 Non-Invasive

Active, not recruiting
Clinical Trial NCT06689215 is an observational study for Heart Failure, Congestive that is active, not recruiting. It started on 21 October 2024 with plans to enroll 30 participants. Led by Nihon Kohden, it is expected to complete by 30 March 2027. The latest data from ClinicalTrials.gov was last updated on 13 February 2026.
Brief Summary
Comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.
Detailed Description
The conventional method used to measure central venous pressure has limitations since it is an invasive procedure that requires a central venous catheter. To overcome this challenge, a new technology to assess CVP non-invasively using an oscillometric method is being developed. It is called enclosed zone central venous pressure (ezCVP). A comparison study of ezCVP and CVP is needed to determine accuracy and reproduci...Show More
Official Title

Comparison Study of ezCVP and CVP

Conditions
Heart Failure, Congestive
Other Study IDs
  • 74Ag- 00009
NCT ID Number
NCT06689215
Start Date (Actual)
2024-10-21
Last Update Posted
2026-02-13
Completion Date (Estimated)
2027-03-30
Enrollment (Estimated)
30
Study Type
Observational
Status
Active, not recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
N/A
Non-invasive central venous pressure
Non-invasive method to measure central venous pressure indicator
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Non-invasive pressure indicator
Evaluate sensitivity and specificity of ezCVP indication based on the case where CVP is in a 'low range' (0 \< CVP \< 10 mmHg) or 'high range' (\>= 10 mmHg)
1-7 days
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Direction of change
Correlate the directionality of ezCVP change to invasive CVP change over time (i.e., increasing, decreasing or remaining stable).
1-7 days
Correlation with invasive CVP
Quantify the agreement between ezCVP (non-invasive) and CVP (invasive)
1-7 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Adult age over 18 years.
  2. Arm circumference is 18 cm to 55 cm
  3. Subject will have an existing indwelling central venous catheter during their ICU stay
  4. Subject or legally authorized representative (LAR) is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent
  5. Subject or LAR is willing and able to comply with protocol procedures

  1. Finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff.
  2. Pregnant (self-reported)
  3. Upper extremity deep venous thrombosis currently being treated
  4. Severe skin disease involving the upper arm(s)
  5. Study investigator may exclude patients based on clinical judgement
Nihon Kohden logoNihon Kohden
No contact data.
1 Study Locations in 1 Countries

California

Stanford University Hospital, Stanford, California, 94305, United States